Senior Scientist 1, Analytical Development

About the role

Crinetics is a pharmaceutical company focused on developing therapies for endocrine diseases and tumors. This role is part of a team committed to advancing innovative treatments that improve patient lives.

Responsibilities

• Develop, optimize, and execute analytical methods for drug substance and drug product programs.
• Lead analytical activities for assigned projects, including method development, validation, transfer, and troubleshooting.
• Collaborate with cross-functional partners in CMC, Technical Operations, Quality, Regulatory Affairs, and external vendors to support development and regulatory strategies.
• Provide hands-on expertise in chromatographic method development, dissolution testing, and small molecule characterization.
• Apply phase-appropriate analytical strategies to method development, stability studies, impurity profiling, forced degradation studies, comparability assessments, and method lifecycle management.
• Generate high-quality, scientifically sound data and recommend analytical strategies and development approaches.
• Communicate analytical findings, risks, and recommendations clearly through technical documents and presentations.
• Support regulatory filings and provide scientific oversight for quality events.
• Perform other duties as assigned.

Requirements

• Ph.D. in analytical chemistry or related field with at least 5 years of relevant hands-on experience, or Masters with 13 years or Bachelor’s with 15 years of experience.
• Strong technical expertise in analytical testing, method development, and phase-appropriate qualification/validation, characterization, and support of stability programs for small molecule APIs and DP's.
• Experience with techniques including HPLC, UPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, and solid-state characterization tools like DSC, TGA, DVS, XRPD, microscopy.
• Knowledge of cGMP requirements and regulatory guidance (FDA, ICH).
• Excellent written and oral communication skills, including the drafting and reviewing of technical documents and presenting data to peers, management, and external partners.
• Ability to work in a goal-oriented and team-oriented setting, handle competing priorities, and maintain high attention to detail.
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project).

Qualifications

• Biology and chemical laboratory experience needed.
• Environmental health and safety requirements apply.

Skills

• Hands-on expertise in chromatographic method development, dissolution testing, and small molecule characterization.
• Technical proficiency with HPLC, UPLC, and solid-state characterization tools.
• Experience with additional areas of pharmaceutical development (solid state analysis, physical characterization, drug product dissolution, in-use stability studies).
• Knowledge of cGMP requirements and regulatory guidance.
• Excellent written and oral communication skills.
• Ability to work in a goal-oriented and team-oriented setting.
• Intermediate to advanced software skills.

Benefits

• Discretionary annual target bonus.
• Stock options.
• Employee Stock Purchase Plan (ESPP).
• 401(k) match.
• Top-notch health insurance plans.
• 20 days of paid time off.
• 10 paid holidays.
• Winter company shutdown.

Pay

The salary range for this position is: $117,000 - $146,000.

Schedule

Full-time position.